The Effect of Psycho-education on Clinical Outcomes Among Patients With a First Episode Psychosis in Central Uganda - A Pilot Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Makerere University
- Enrollment
- 80
- Primary Endpoint
- Reduction in symptom severity
Study Overview
Brief Summary
Background: Psychotic disorders which the investigators have operationally defined as any of schizophrenia or schizophrenia spectrum disorder, brief psychotic episode, or bipolar affective disorders are severe forms of mental illness that contribute to significant morbidity and mortality primarily due to high rates of relapse. Delivering psycho-education messages about disease etiology, their signs and symptoms, as well as the benefits of adhering to treatment have been shown to reduce relapse among individuals with psychoses in high income countries. However, little has been done to examine the efficacy of this intervention in low resourced settings like Uganda.
Objective: The study objective is to examine the efficacy of psycho-education on symptom severity, stigma and retention in care.
Methods: The Investigators will recruit 80 adult patients (aged ≥18 years) who have been diagnosed with a First Episode Psychosis (FEP) and received antipsychotic medication at Butabika Hospital. Participants should be ready for discharge and reside within a 21km radius from Kampala city. The investigators will use a simple random technique to randomize the 80 participants to either receive 6 sessions of psycho-education from village health team members (VHTs) with a family member (n=40) or routine care (n=40). The investigators will collect symptom severity, stigma and retention in care data over 24 weeks.
Data analysis plans: The investigators will conduct an intention to treat analysis and compare the groups at baseline, weeks 4, 12 and 24. We will assess the effects of the intervention on symptom severity. The investigators will assess for potential confounders, mediators and effect modifiers using generalized linear estimates. Between-subject analysis at week 24 will be used to assess if there is a significant difference in the mean severity scores between the 2 arms.
Conclusion: Findings from this research will throw more light with regards to the preliminary efficacy of the use of psycho-education for individuals with psychosis.
Detailed Description
Methods
- Study setting: The study will be conducted at the Butabika National Mental Referral Hospital in Kampala, a 600 bed hospital located 13km east of Kampala city
- Eligibility criteria: Individuals will be eligible if they have been diagnosed with a First Episode Psychosis ( FEP) and considered (by the attending health care practitioner) to have demonstrable resolution of active symptoms following the use of antipsychotic medications, and deemed clinically stable for a discharge. The diagnosis of FEP will be confirmed through an interview conducted a by a research assistant (RA) using the Mini International Neuropsychiatric Instrument (MINI). Participants (adults ≥18 years) will be required to provide written informed consent and should reside within a 21 km radius from Kampala.
Exclusion criteria: Individuals will be excluded if they present with a psychosis secondary to a medical or substance use disorder. 3. Sample size and power calculation: The investigators calculated the size of effects that our sample will be able to detect a clinically significant difference in symptom severity (primary outcome) between the two arms. A sample size of 80 (n=40 per arm) will provide sufficient power to detect a 50% difference in mean symptom severity levels between the two arms using a two-tailed z-test of proportions with 80% power and 95% confidence interval. Whereas this study is not adequately powered to detect statistical significance, our findings will provide the investigators with an effect size that can be used in sample size calculation of a powered randomized control trial (RCT). 4. Data collection methods
i) Training: RAs and VHTs will each undergo 4-day's training in the study procedures.
ii) Random sequence allocation: The investigators will use a simple random technique to randomize participants. Our biostatistician will write the words intervention, insert them in 40 opaque envelops and seal them, then do the same for controls
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
We will mask participants at the point of randomization. They will pick a piece of paper that dictates which arm they will belong
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •individuals will be eligible if they have been diagnosed with a FEP and considered (by the attending health care practitioner) to have demonstrable resolution of active symptoms following the use of antipsychotic medications, and deemed clinically stable for a discharge. The diagnosis of FEP will be confirmed through an interview conducted a by a research assistant (RA) using the Mini International Neuropsychiatric Instrument (M.I.N.I). Participants (adults ≥18 years) will be required to provide written informed consent and should reside within a 21 km radius from Kampala.
Exclusion Criteria
- •individuals will be excluded if they present with a psychosis secondary to a medical or substance use disorder
Arms & Interventions
Experimental
After discharge, the program manager will link the participants with a VHT nearest to them. The participants (randomized to the intervention arm) will be informed during the consent procedure that they will undergo 6 psycho-education sessions (1 per month) together with a family member at the participant's residence. The VHTs and participants will meet and schedule appointments for the next engagements. This shall be done on a case by case basis. Some psycho-education sessions could take place in the patient's residence, others in the nearest public space (school or church or mosque compounds). The investigators will document where the majority of these sessions happen. This will help the investigators document feasibility. The PI and RAs will sit in some of the sessions during the pilot phase of data collection to ensure fidelity to the manual.
Intervention: Psycho-education (Behavioral)
Usual care arm
Participants will receive usual care
Intervention: Psycho-education (Behavioral)
Outcomes
Primary Outcomes
Reduction in symptom severity
Time Frame: 6 Months
The investigators will measure a reduction in symptom severity as measured by the PANSS or YMRS
Secondary Outcomes
No secondary outcomes reported
Investigators
College of Health Sciences
Dr Dickens Akena
Makerere University